3 Things mHealth Startups Need To Know Now About Regs

Jeff Rowe | Government Health IT | December 2, 2013

When entrepreneurs eyeing the mobile healthcare technology space start planning their new venture, they probably don’t have “regulatory strategy” on their task list. They forget that they’re entering one of the most heavily regulated industries, and how they manage that can have a significant impact on whether they're successful.

Ryan Minarovich, co-founder and CEO of the Tenzing Group, will address that gap at the HIMSS Media mHealth Summit. On Monday, December 9, he will give an overview of what they should know about FDA regulations in the mHealth space. His company specializes in educating mHealth app developers and start-ups on FDA regulatory procedures and requirements, and he says not enough mHealth entrepreneurs are remembering to factor regulations into their business plans.

According to Minarovich, the impetus for his consulting business came in part from the two summers he spent working for HIMSS while in law school. One of his tasks was to conduct a legislative analysis of potential impacts of the Affordable Care Act on IT firms. While conducting his research, he said he realized many startups haven’t given much thought to the potential impact of FDA regulation.